What is a Class I Recall Anyway?

The U.S. Food and Drug Administration (FDA) is responsible for overseeing the safety of prescription and over-the-counter drugs and medical devices. When they receive information about a potential defect in these products, or when a manufacturer recalls one, the FDA may make a recall announcement about that product to alert doctors and patients to the issue.

Whether the FDA or the manufacturer initiates the recall, the FDA will often categorize that recall into one of three classifications. Let’s look at what these classifications are, and what they may mean in a potential personal injury lawsuit.

What is a Product Recall?

Before we examine the FDA’s classifications, let’s review what a product recall is.

If a product is found to be defective or potentially unsafe, the manufacturer may elect to retrieve it or remove it from the market to protect public safety. Sometimes a government agency like the FDA or the Consumer Product Safety Commission will urge or require the manufacturer to recall a product they deem to be dangerous.

For example, a manufacturer may discover that certain lots of its pain-relieving drugs were contaminated with a toxic ingredient at one of the production plants, for instance, and move to recall those drugs so that they don’t hurt anyone. Or a company producing hip replacements may find out that some of its products are breaking more commonly than they should.

A partial recall involves only some of the products, while a complete recall involves all of them. Typically, the companies ask customers to return the products for a free replacement, repair, or refund.

Three Classes of FDA Recalls

The FDA may classify medical recalls in one of the following three categories:

  1. Class 1 recall: This is the most serious type of recall, and indicates that use of the product may cause serious adverse health consequences or even death.
  2. Class 2 recall: This indicates that the product may cause temporary or medically reversible adverse health consequences, or may suggest that the probability of serious health consequences is remote.
  3. Class 3 recall: The least serious of the three, this indicates that exposure to the product is not likely to cause any health problems.

Understanding these classifications can help you determine the seriousness of any recall that may affect the drugs you’re taking or the medical devices you may be using. If you see a Class I recall on any product that you’re familiar with, be sure to pay close attention to it and follow the instructions.

If you were injured by a product and then find out that the product was the subject of a recall, that can help you in a personal injury lawsuit, as it provides evidence of a potential defect in the product. A personal injury attorney can help you determine if the product in your case was part of a product recall and if so, why. Such evidence may support any claims you make in your case, increasing your chances of winning compensation.